(60 days)
The FOSFATEMIA UV AA test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
End point method. Inorganic phosphate reacts with molybdate in the presence of acid to form a phosphomolybdate complex that is measured photometrically at 340 nm.
This document describes the Wiener lab. FOSFATEMIA UV AA Test System, an in-vitro diagnostic device for measuring inorganic phosphorus. The device's acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Wiener lab. FOSFATEMIA UV AA Test System are primarily based on its equivalence and performance characteristics compared to the predicate device, the ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system.
| Acceptance Criteria (based on Predicate Device) | Wiener lab. FOSFATEMIA UV AA Reported Performance |
|---|---|
| Intended Use: Measurement of inorganic phosphorus. | Same: Intended to measure inorganic phosphorus in serum, plasma and urine. Used in diagnosis and treatment of various disorders (parathyroid gland and kidney diseases, vitamin D imbalance). |
| Test Principle: End point method. Inorganic phosphate reacts with molybdate in the presence of sulfuric acid to form a phosphomolybdate complex measured photometrically at 340 nm. | Same: End point method. Inorganic phosphate reacts with molybdate in the presence of acid to form a phosphomolybdate complex measured photometrically at 340 nm. |
| Essential Components: Ammonium molybdate - Sulfuric acid. | Similar: R: Sulfuric acid and Ammonium molybdate. |
| Reagents: R1: Sulfuric acid and detergent. R2: Sulfuric acid, Ammonium molybdate and Sodium chloride. | R: Sulfuric acid and Ammonium molybdate. (Slight difference in multi-reagent vs. single reagent, but essential components are same) |
| Instability or Deterioration of Reagents: Not specified for predicate. | Absorbance of Reagent > 0.500 (This is a self-defined acceptance criterion for reagent stability). |
| Working Temperature Range: 25 – 37°C. | Same (implied, as no difference is stated, indicating equivalence). |
| Stability of Final Color: Not specified for predicate. | 20 minutes (This is a self-defined acceptance criterion for final color stability). |
| Wavelength of Reading: 340 nm. | Same: 340 nm. |
| Calibration: Single point. | Same: Single point. |
| Linearity: 20 mg/dl. | 16 mg/dl (This is a difference from the predicate, indicating it did not meet the predicate's linearity, but it is reported as its own performance characteristic. The document later concludes "substantial equivalency" despite this difference). |
| Minimum Detection Limit: Not specified for predicate. | 0.11 mg/dl (This is a self-defined performance characteristic). |
2. Sample Sizes Used for Test Set and Data Provenance
The provided document describes the device in terms of its characteristics and comparison to a predicate device for 510(k) submission. It does not present data from a clinical test set with specific sample sizes for patients or samples used to validate its performance. The information provided is about the device's technical specifications and a general claim of substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts
This document does not mention the use of experts to establish ground truth for a test set. This type of information would typically be found in detailed performance studies, which are not included here. The "ground truth" for the comparison is the specifications of the predicate device.
4. Adjudication Method for the Test Set
As no specific clinical performance study or test set evaluation is detailed, no adjudication method is mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No MRMC comparative effectiveness study was performed or described in this document. This device is an in-vitro diagnostic test, not a medical imaging device or AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This device is an in-vitro diagnostic test, not an algorithm in the typical sense of AI/ML. Its performance is inherently standalone as it performs chemical reactions and provides a quantitative measurement. The information provided is essentially its standalone performance characteristics in comparison to a predicate device.
7. Type of Ground Truth Used
The "ground truth" implicitly used for the purpose of this 510(k) submission is the established performance characteristics and specifications of the legally marketed predicate device (ROCHE DIAGNOSTICS / BOEHRINGER MANNHEIM CORP. INORGANIC PHOSPHORUS test system). The Wiener lab. device is asserting its equivalency to these established standards.
8. Sample Size for the Training Set
This document does not report on a training set sample size. Such a concept is typically relevant for machine learning algorithms, which is not the nature of this in-vitro diagnostic device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set described for this device, the method for establishing ground truth for a training set is not applicable and therefore not provided.
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.